Morpholine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 20-23, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD 404 guideline. GLP compliant. There were no significant deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report Date:

1997

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test control not performed

GLP compliance:

yes (incl. certificate)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material: Morpholine
- Physical state: clear colorless liquid
- Lot/batch No.: B-1-20
- Purity test date: responsibility of the Sponsor
- Stability under test conditions: responsibility of the Sponsor
- Other:amount submitted: 668.38g (test article and container)/pH:8 (paper indicator)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Covance,The Development Services Company, Denver, PA, USA
- Age at study initiation: 19-21 weeks
- Weight at study initiation: 2.710-3.278 kg
- Housing: rabbits were housed individually in stainless steel cages
- Diet: PMI Certified Lab Rabbit HF Diet
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 16-21°C
- Humidity: 25-70 %
- Photoperiod: 12 hours light/12 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL/site

Duration of treatment / exposure:

3 min

Observation period:

3 and 55 min

Number of animals:

6 animals (3 males, 3 females)

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk (clipped free of fur)

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 3 min

SCORING SYSTEM:
Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 2/6

Time point:

other: immediate after exposure

Score:

>= 2

Max. score:

4

Remarks on result:

other: well-defined erythema

Results 2

Irritation parameter:

erythema score

Basis:

animal: 4/6

Time point:

other: immediate after exposure

Score:

>= 1

Max. score:

4

Remarks on result:

other: very slight erythema

Results 3

Irritation parameter:

edema score

Basis:

animal: 3/6

Time point:

other: immediate after exposure

Score:

>= 1

Max. score:

4

Remarks on result:

other: very slight edema

Results 4

Irritation parameter:

edema score

Basis:

animal: 3/6

Time point:

other: immediate after exposure

Score:

>= 0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal: 6/6

Time point:

other: 55min

Score:

>= 4

Max. score:

4

Remarks on result:

other: severe erythema, necrosis

Results 6

Irritation parameter:

edema score

Basis:

animal: 6/6

Time point:

other: 55min

Score:

>= 4

Max. score:

4

Remarks on result:

other: severe edema, necrosis

Irritant / corrosive response data:

In all animals severe etyhema, severe oedema and necrosis was observed after 55 min.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: other: DOT Classification (Packaging group I)

Conclusions:

Morpholine was considered to be a severe irritant. The test article was considered corrosive according to the DOT Classification (Packaging group I).

Executive summary:

In this primary dermal irritation study (Huntsman, 1997), 0.5 mL of Morpholine was applied to one site on the clipped dorsal trunk of 6 New Zealand White rabbits (3 males and 3 females) for an exposure period of 3 minutes. Observations for responses were recorded immediately after unwrap and at 55 minutes. Grading of irritation was performed according to the method of Draize. Following an exposure period of 3 minutes, severe erythema, severe oedema and necrosis were observed. Therefore, Morpholine was considered to be a severe irritant and was considered as corrosive according to DOT classification (Packaging group 1).

This study is classified as acceptable. It satisfies the requirements of OECD test guideline 404.